Clinical Study to Evaluate the Efficacy and Safety of GNS-212-E in Bowel Preparation for Colonoscopy

Inclusion criteria

• Adult men and women between 19 years and 79 age or older as of the date of consent in writing
• 19 kg/㎡ ≤ BMI < 30 kg/㎡
• a prospective colonoscopy patient
• For women of childbearing potential, those who agree to use a medically acceptable contraceptive method* during the clinical trial period

*hormonal contraceptive, implantation of intrauterine device or intrauterine system, Infertility procedures/surgery (e.g., bilateral ovarian ligation, vasectomy)

• A person who voluntarily agrees to participate in this clinical trial and signs a written agreement Abbreviation
• Women of childbearing potential must have a negative serum or urine pregnancy test before Investigational Product administration

Exclusion criteria

• A person having constipation who is regularly administered laxatives or gastrointestinal motility promoters
• A person with a history of significant gastrointestinal surgeries, including colonic resection, subtotal colectomy, abdominoperineal resection
• A person diagnosed with acute coronary disease, arrhythmia, cardiomyopathy, cardiac valvular disease, aortic and peripheral vascular disease
• Active infection or high fever above 38°C
• Uncontrolled chronic medical illnesses or suspected symptoms that hinder participation such as major cardiac, renal, and metabolic (ex, Subjects with severe renal disease).
• Clinically significant abnormal laboratory values of screening.(Creatinine, AST or ALT )
• Active hepatitis B or hepatitis C with positive HBsAg and HCV Ab tests at screening
• Positive for Human Immuno-deficiency Virus (HIV) at the time of screening
• Severe nausea or vomiting
• Severe abdominal distension or abdominal pain
• A person prone to aspiration or reflux
• A person who undergoes colonoscopy for the following therapeutic purpose (1) balloon dilatation of the stenosis area (2) non-toxic giant colon or decompression of the S-phase colitis (sigmoid volvulus) (3) Removal of foreign substances (4) Vascular dysplasia, ulcer, tumor and treatment of bleeding after polypectomy
• A person who is hypersensitive to the ingredients of a clinical trial drug
• Pregnant woman or a lactating woman
• A person who has serious mental disabilities
• A person who requires the administration of drugs prohibited from concomitant use
• A person who is administered another investigational drug or has been provided with a clinical trial medical device within 6 months prior to participating in a clinical trial
• The person whom the investigator determines to be unsuitable for this study